Epilepsan Warnings

Hepatotoxicity: Liver failure that causes death has been reported in patients using Valproic Acid. The use of Valproic Acid especially in children under 2 years can lead to the risk of fatal hepatotoxicity. Use of Valproic Acid in patients using 2 or more anticonvulsant drugs, patients with congenital metabolic disorders accompanied by mental retardation, and patients with organic mental disease, Valproic Acid must be used with extreme caution and as a monotherapy. The benefits of therapy must be considered against the risk, the risk of fatal hepatotoxicity decreases in groups of patients over the age of 2 years. This event usually occurs during the first 6 months of therapy with Valproic Acid. Serious or fatal hepatotoxicity can be preceded by non specific symptoms, such as loss of control over seizures, malaise, weakness, lethargy, facial edema, anorexia and vomiting. Patients must be closely monitored for these symptoms. Liver function tests should be done before therapy and at fairly frequent intervals thereafter, especially during the first 6 months of therapy.
Teratogenicity: Valproate can produce teratogenic effects such as damage of neural tubes (e.g. spina bifida). Therefore, the use of Valproate in woman who are potentially pregnant requires consideration of the benefits and risks to the fetus. This is very important for therapy in conditions that the cure is spontan and is not related to permanent damage or risk of death (e.g. migraine) are considered for administration.
Pancreatitis: Cases of life-threatening pancreatitis have been reported in children and adult patients using Valproate. Some cases are hemorrhages with rapid progression from the onset of symptoms to death. Cases that have been reported occur shortly at the beginning of use and also after several years of use. Patients and families should be warned if abdominal pain, nausea, vomiting, and/or anorexia are symptoms of pancreatitis that requires medical treatment. If the patient is diagnosed with pancreatitis, the use of Valproate must be stopped. Alternative therapies for other medical conditions must be given according to clinical indications (see Precautions).